Once Daily Dosing for Kidney Transplant
(OnceDaily Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byJohn Gill, MD
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of British Columbia
No Placebo Group
Trial Summary
What is the purpose of this trial?Patient failure to take medications as prescribed (medication non-adherence) is now identified as an important cause of kidney transplant failure. The availability of new drugs that are taken once daily may improve patient adherence compared to older drugs that had to be taken twice per day. In this study, patients will be converted to a medication schedule where all medications are taken once daily with the goal of improving patient adherence and satisfaction.
Eligibility Criteria
This trial is for kidney transplant recipients aged 12 and older who are at least one year post-transplantation, on specific immunosuppressants, and considered low risk. It's not for those with high antibody levels, unstable graft function, active infections or malignancies, or a history of non-adherence.Inclusion Criteria
People who are at least 12 years old and adults who are at least 18 years old.
You are taking medications like tacrolimus, cyclosporin, or Advagraf.
You have only had one transplant and are considered low risk by the main doctor before being asked to join the study.
+5 more
Exclusion Criteria
You have had treatment to reduce your body's reaction to certain proteins or blood type differences in the past.
Your Panel Reactive Antibody (PRA) level is 30% or higher before the transplantation.
Unable to provide informed consent
+8 more
Participant Groups
The study tests if switching patients to once-daily medication regimens improves adherence and satisfaction. This includes converting to Advagraf (a once-daily immunosuppressant) and adjusting other meds to a single daily dose.
1Treatment groups
Experimental Treatment
Group I: Conversion to once daily dosingExperimental Treatment3 Interventions
The conversion to a once daily dosing regimen will be accomplished in three phases (1-conversion to Advagraf; 2-conversion of non-immunosuppressant drugs and; 3-conversion of patients taking twice daily MPA to once daily MPA). No control group.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
BC Children HospitalVancouver, Canada
St. Paul's HospitalVancouver, Canada
Vancouver General HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
Astellas Pharma Canada, Inc.Industry Sponsor